A phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer.

A phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer. - Combination therapy of gemcitabine and hyperthermia in unresectable gallbladder cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002824

Enrollment

Registered

2009-12-03

Start date

2009-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable gallbladder cancer

Interventions

One cycle of the chemotherapy regimen consist of a drip infusion of 1000mg/m2 of GEM weekly for 3 weeks and 1 week off, and this was repeated every 4 weeks. Patients receive hyperthermia once per week

Thermotron RF8. The duration of heating session is from 40 minutes to 60 minutes.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible criteria in this study are as follows: 1.Histologically confirmed unresectable gallbladder cancer 2.Existing measurable lesion(more than two times thickness slice resolution with CT) 3.Over 20, and under 80 years of age 4.Without active other malignancy 5.No prior treatment(radiation therapy,chemotherapy,immunotherapy) for gallbladder cancer 6.PS is 0, 1 or 2 7.Sufficient functions of main organ (bone marrow, kidney, heart) 8.Without severe complications or inadequate physical condition, as diagnosed by primary physician 9.Written informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria in this study are as follows: 1. Interstitial pneumonitis, pulmonary fibrosis with radiological findings 2.Presence of uncontrolled diabetes, severe liver dysfunction, unstable angina, myocardial infarction within three months. 3.Presence of active severe infection 4.Pregnant, lactating women or women with suspected pregnancy. 5.Medical history of severe hypersensitivity. 6.Severe complications 7.Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
survival time, progression-free survival time, safety, performance status	—

Countries

Japan

Contacts

Public ContactSatoshi Kokura

Graduate School of Medical Science, Kyoto Prefectural University of Medicine Molecular Gastroenterology and Hepatology

s-kokura@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026